论文部分内容阅读
目的调研我国公众发生药品不良反应的现况,分析我国实施药品不良反应公众报告的必要性和可行性。方法采取配额抽样的方法,选择公众和不良反应监测人员进行问卷调查,了解不良反应发生现况、处理方法和公众报告需求,采用统计图、统计表、卡方检验和秩和检验进行统计分析。结果共收到有效公众调查表5 394份,监测人员调查表185份。调查对象及家人发生过药品不良反应的2 032人(占37.7%)。若发生不良反应,直接向药品不良反应监测机构或食品药品监督管理部门报告者占17.5%,16.2%的人不知道报告途径。2015年公众主动报告数量仅占总数的0.11%。有78.0%的监测机构和87.0%的公众认为应建立药品不良反应公众报告系统,有47.5%的省级监测机构表示有能力承担该工作。结论我国应开展广泛宣传,提高公众对不良反应的认知度和自我保护意识;同时完善不良反应监测的法律法规体系,逐步建立药品不良反应公众报告机制。
Objective To investigate the current status of adverse drug reactions in our country and to analyze the necessity and feasibility of public reporting of adverse drug reactions in China. Methods Quota sampling method was used to select the public and adverse reaction monitor personnel to conduct questionnaire survey to understand the occurrence of adverse reactions, treatment methods and public reporting needs, using statistical charts, statistical tables, chi-square test and rank sum test for statistical analysis. A total of 5 394 valid public questionnaires and 185 monitoring questionnaires were received. There were 2 032 (37.7%) of the respondents and their families who had adverse drug reactions. If an adverse reaction occurs, 17.5% of the respondents directly report to the adverse drug reaction monitoring agency or the food and drug regulatory department, and 16.2% do not know the reporting channel. The number of public initiative reports in 2015 only accounted for 0.11% of the total. 78.0% of the monitoring agencies and 87.0% of the public think that a public reporting system for adverse drug reactions should be established, and 47.5% of the provincial monitoring agencies have indicated that they are capable of undertaking the work. Conclusions China should conduct extensive publicity to raise public awareness of adverse reactions and self-protection awareness. At the same time, we should improve laws and regulations on adverse reaction monitoring and gradually establish a public reporting mechanism for adverse drug reactions.